Class IIIDrug
Trokendi XR recall
Summary
Supernus Pharmaceuticals, Inc. is recalling Trokendi XR (drug). According to the FDA report, the reason is: Failed dissolution specifications. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- Product
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- Reason
- Failed dissolution specifications.
- Lot / code info
- Lot# 2145283, Exp Date: 31-Mar-2030.
- Quantity
- 11304 bottles
- Distribution
- US Nationwide.
- Recalling company
- Supernus Pharmaceuticals, Inc., Rockville, MD United States
- Recall started
- August 31, 2026
- FDA report date
- September 9, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0833-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Supernus Pharmaceuticals, Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.